FDA 510(k) Application Details - K002566

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K002566
Device Name Activator, Ultraviolet, For Polymerization
Applicant LUMALITE, INC.
2810 VIA ORANGE WAY, STE. B
SPRING VALLEY, CA 91978 US
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Contact JOSEPH M FOREHAND
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 08/17/2000
Decision Date 10/19/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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